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Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399630
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Aestique Medical Center

Brief Summary:
Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: Injection of Autologous Adipose Tissue Other: Injection of lactated ringers Not Applicable

Detailed Description:
This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind parallel groups assignment
Masking: Double (Participant, Care Provider)
Masking Description: Patient and treating physician are both blinded, being that neither are aware of which knee received the autologous adipose tissue injection and which knee received the placebo lactated ringers injection
Primary Purpose: Treatment
Official Title: Injection of Autologous Adipose Tissue for Treatment of Osteoarthritis in the Knee: A Controlled, Double-Blinded Trial
Actual Study Start Date : August 9, 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Injection of Autologous Adipose Tissue
Treatment knee receives injection of 1.5 cc's of adipose tissue mixed with 1.5 cc's of Lactated Ringers
Other: Injection of Autologous Adipose Tissue
Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis

Placebo Comparator: Injection of Lactated Ringers
Placebo control group receives injection of 3 cc's of Lactated Ringers with no adipose tissue
Other: Injection of lactated ringers
Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.




Primary Outcome Measures :
  1. Safety - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    Subjects will be monitored for adverse events


Secondary Outcome Measures :
  1. Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for pain will be recorded

  2. Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for function will be recorded

  3. Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for stiffness will be recorded


Other Outcome Measures:
  1. Efficacy - Change in Pain Scores on the VAS Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for pain will be recorded

  2. Efficacy - Change in Function Scores on the VAS Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for function will be recorded

  3. Efficacy - Change in Stiffness Scores on the VAS Scale at All Follow-Up Visits [ Time Frame: 1 week, 6 weeks, 3 months, and 6 months ]
    Patient outcomes for stiffness will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans.
  2. Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
  3. Males and females 40-75 years old.
  4. Participants will be in good health (ASA Class I-II) with a BMI < 35.
  5. Continued pain in the knee despite conservative therapies for at least 6 months.
  6. Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points).
  7. Must speak, read and understand English.
  8. Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

  1. Participants who have had surgery of either knee within 6 months prior to the screening visit.
  2. Participants who have had a major injury to either knee within 12 months prior to enrolling in the study.
  3. Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP).
  4. Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication.
  5. Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee.
  6. Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit.
  7. Participants that are allergic to lidocaine, epinephrine or valium
  8. History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection
  9. Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399630


Locations
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United States, Pennsylvania
Aestique Ambulatory Surgical Center
Greensburg, Pennsylvania, United States, 15601
DNA Advanced Pain Treatment
Greensburg, Pennsylvania, United States, 15601
Sponsors and Collaborators
Aestique Medical Center
Investigators
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Principal Investigator: Theodore Lazzaro, MD Aestique Ambulatory Surgical Center

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Responsible Party: Aestique Medical Center
ClinicalTrials.gov Identifier: NCT03399630    
Other Study ID Numbers: ATOA-01
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aestique Medical Center:
Osteo Arthritis Knee
Autologous Adipose Tissue
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases